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PHARMA/POLICY: GAO confirms the corruption of science forced on the FDA

Just in case there was any doubt that the White House’s filthy fingerprints were all over the Plan B non-decision, the Congressional GAO is out with a  report that call the FDA’s Plan B decision process ‘unusual’. And of course points out that senior FDA leadership (i.e. Crawford and his cronies) forced this over the heads of the FDA staffers responsible for such decisions, and even made the decision before the evidence was in.

The GAO probe found that high-level FDA officials were more involved than is usually the case in decisions to approve drugs for over-the-counter use. Also, investigators found conflicting accounts as to whether the decision to reject the application for OTC use was made before the agency’s reviews were finished, the report said. Also, three FDA directors who normally would have been responsible for approving the decision to reject the application did not do so because they disagreed with it, the report found.

This is only one small battle in the war to keep the creationists and fundamentalists loons outside of science. A battle that we’ve lost.

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BLOGS: Typepad apologises for hassles

So I managed to lose some work because of Typepad’s system problems last week. They have apologized and offered all their users a free month/fortnight/45 days rebate.  Very nice of them.

I also lost some work (hence no long post today) because late last night I hit Ctrl-W by mistake when I meant to hit Shift-W.  That’s a windows command/shortcut that closes the window you’re in, and when it’s an I-Explorer window like the one using Typepad (or any other program which is hosted), it closes and you’ve lost whatever you haven’t saved. And of course it happens when you haven’t saved for 20 minutes….really maddening. And of course as it’s Microsoft you cannot turn that feature off.

So I’m now trying out client side blog editors. I’ve suggested to Type pad that they should create their own, or cut a deal with the best one.  they referred me to w.bloggar, but having used it, it doesn’t have a live WISYWIG editor. Sad, cos it looks powerful and it’s free. Blogjet is only free for 30 days but as it has got such an editor I’m trying it out now.  I’ll be back with the long post on topic tomorrow instead.

POLICY/POLITICS: Health Reform may be back on the national agenda

Here’s my editorial from FierceHealthcare this morning.

This week may or may not have been a political harbinger for the coming years. Following a disastrous year for the Administration, Democrats have been claiming victory following wins in Virginia, New Jersey and California. Meanwhile, voters in California and Washington rejected measures that would have limited the activities (and incomes) of drug companies and trial lawyers. In Massachusetts, there may be the start of a compromise designed to get universal insurance (of a sort) for the state, and several other states are looking at the issue. Of course, nationally this will only mean something if the Democrats really carry their (so far modest) victories into the Congress next year and the White House in three years. That of course is a long time away. But health care is fast becoming the number one domestic issue and a Democratic majority will feel compelled to have another crack at it.

POLICY: Did you need more evidence that being poor and sick is bad for your financial health?

No, you’ve seen plenty including what’s being described in various places as my "smackdown" of Medpundit last week. but in case you weren’t quite satisfied, another liberal bleeding heart group (reported by capitalist tools Forbes of all people) has found in a survey of low income people (mostly those in households earning under $35,000) that medical debt is prevalent. Nearly half (46%) have got it, and as little as $500 in medical debt can restrict access to housing, can contribute towards forclosure, bankruptcy et al. Note that more than 40% of those with medical debt had health insurance at the time they ran up the debt. Which means that those Americans who haven’t stashed away their $2,000 for deductibles et al in their HSAs are going to be the road-kill of those driving the HSA/CDHP bus.  But you knew that anyway, right?

The survey is from The Access Point, and the press release is here. The methodology looks sound to me and it back up plenty of prior research about the subject that tells us what we already know.

PBMs: The future of PBMs–a work in progress

There’s an interesting article in AISHealth.com’s Business News of the Week called Why the Plans of a Major Drug Purchasing Coalition Did Not Work. The quick story is that a group of employers got together in late 2004 and made an attempt to negotiate pricing direct with the pharma companies.  The pharma companies, who are quite happy with the way they work with the PBMs, and who also realized that this coalition was too small (only 53 companies and 5 million lives) to matter, and that they could easily face them down. And that’s what happened.

But instead the companies involved were rounded up by their benefit consultant (Hewitt) and demanded a more transparent approach from their PBMs. So they have got that with some smaller PBMs (Medimpact, Aetna & Walgreens) offering to supply "transparent" services.  That is, tell them what rebates they are getting and therefore the true price they are paying for drugs. Now this is very very early days. No one has actually switched over to using these plans yet and won’t until next year. Plus more importantly given the buying power of the big 3 (Medco, Caremark and Express Scripts) it’s very likely that the transparent PBM will still have a price disadvantage overall. And that is before the big 3 target the transparent guys in a price war for their clients.

However, we may be seeing a bigger sea change as a Federal Appeals court yesterday upheld a Maine state law that said that PBMs must reveal to their Maine customers what rebates they get, and must have the best interests of their clients at heart when they negotiate with drug companies. (Stop and think about what that last sentence says about the PBMs’ behavior thus far!!)

Now this information does not have to be made public (and I’m sure PBMs will design contracts banning their clients from revealing that information). The PBMs of course will fight this to the Supreme Court and fight it state by state. And of course if you believe their public statements, all this fuss about them making money off rebates and price gouging their clients (not to mention bribing health plans) can’t possibly be true. No sir, No way. Here’s what Express Scripts’ CEO Barrett Toan said about these accusations in Health Affairs earlier this year.

Atlas: Let’s turn to some challenges to the PBM business model. Critics of PBMs assert that PBMs’ way of doing business is inherently at odds with the interests of their customers. Recent actions by various state governments and others seem to bear out this concern. Practices that at minimum raise eyebrows are (1) accepting rebates and administrative fees from drug manufacturers whose products PBMs give preferential status in their formularies, and then retaining unspecified portions of these sums rather than passing them along to customers; (2) paying health plans, ostensibly for data on plan members’ prescription drug usage, in return for securing the health plans’ business; and (3) leveraging the purchaser relationship to steer business away from retail pharmacies to mail-service pharmacies that the PBMs themselves own and that in fact generate large percentages of PBMs’ profits. How do you respond to these critics?Toan: Those are theories. To understand the actual PBM practices, you need to know the details. Those kinds of concerns are overblown because the actual marketplace will not allow those practices to exist.First, the rebates. Express Scripts will not accept any other form of revenue from a manufacturer except in the form of rebates, which are actually discounts from their prices plus administrative fees that are associated with those rebates. We negotiate at arm’s length through a closed bid process run on a two-year cycle. Those bids are opened, and we essentially have our rebates defined. We make those rebate offers known to our customers; that helps them shape their formularies. We pass on a majority of the rebate dollars to the plan sponsor, which can audit the actual payments made by the manufacturers. There’s a great degree of transparency in the rebating process. The idea that these are secret deals, black boxes, is a canard coming from people who oppose what we’re doing—which is making drugs more affordable and a little bit safer.On the issue of whether PBMs should pay plan sponsors for data, we have a very strict policy on that, and I would assume other PBMs have similar policies. First, the amount of money that’s paid to help a group implement its program—for instance, if it has to issue new ID cards or send around new formularies—is reimbursed at fair value. Each of our clients certifies that these are legitimate costs, so that we can be sure that we’re reimbursing for services that had to be provided. Paying data fees is not a practice we would be comfortable with unless there were a very big direct benefit. We do some research that requires an integrated database, so having de-identified medical records can be useful in performing important research. But again, any consideration that might be given for something should be strictly justified based on the actual value to the PBM.

I’ll have more to say about this when the piece Jane Sarasohn-Kahn and I have written on The Prescribing Infrastructure comes out soon, but suffice it to say that "he would say that wouldn’t ‘e". (For those of you who don’t know the quote, go read your early ’60s British scandal history) But in some senses, this battle is part of the last war.  The bigger PBMs are slowly turning to making their money via their mail order services and doing more generic substitution. And of course they now have the Medicare program to mine. Although eventually, I think that will hurt their margins….but eventually is a long time!

PHARMA/PHYSICIANS/POLICY: Oncologists getting paid for reporting data they should report anyway, by Gregory D. Pawelski

Congress has authorized the payment for oncologists reporting whether their treatment adheres to guidelines. Greg Pawelski, who follows the oncology market very carefully, was not too impressed.
When Senate Finance Committee Chairman Chuck Grassley found out that the value of the approximately $300 million-a-year medicare chemotherapy demonstration project to report on a patient’s level of nausea, vomiting, pain and fatigue was for nothing (providers were being paid $130 to simply forward the data that is already collected), they hoodwinked Congress into additional reimbursement to oncologists that report whether their treatment adheres to practice guidelines published by either NCCN or ASCO.

Looks like cancer patients will have to continue overpaying their oncologists and not have access to cutting-edge cancer treatments, and continue to suffer side-effect consequences and even death. The system will continue to serve the clinical investigators and the clinical oncologists, but not serve the best interests of cancer patients.

I think that the concept that some "authoritative" organization (made up primarily of practitioners and researchers with built in conflicts of interest) should determine the "correct" approach to cancer treatment has been very harmful to progress.

BLOGS: Open thread

For those of you wanting to go on at more than 250 words about the health policy competition, how I’m an unfair censor or anything else that takes your fancy. Post your coments in this thread. (I can’t easily move comments so the only real option I had was to delete the previous ones)

For those of you who want to take up Eric’s challenge, which we’ll run for a couple of weeks please go to this post and put it in the comments. But remember 250 words or less and ON topic. Or I will delete them from there.

PHARMA/POLICY/POLITICS: Slick Willie syphons off big Pharma

Today is waste of money election day in California, brought to you mostly by the soon-to-be terminated Governor Arnold. But there are two other props on the ballot on which PhRMA has dropped more than $80 million to muddy the already muddied waters. It looks like Prop 78 which is nominally the one big Pharma "wants" to win and Prop 79 which is the one they actually want to lose (and the reason 78 is on the ballot) are both going down to defeat. Nonetheless I’ve had a voice message from someone claiming to be a surgeon in Fresno telling me to vote yes on 78, paid for by a host of drug companies (and admitting it as such, which is why I don’t think they want it to win).

But of course the really smart people in this state are extracting as much green from big Pharma as they can. The smoothest political operator of them all, former Speaker of the State House and former Mayor of San Francisco and the man whom is surrounded by but never touched by corruption Willie Brown, has successfully put some $500,000 of big pharma’s money in his pocket. Apparently he’s got the trial lawyers to stay neutral and conned some of the NAACP (who also know which way their bread it buttered) to actually support it. Way to go Willie! Sadly that gravy train will be over after today.